Single Use Support has released an add-on of its plate freezing platform for very large volumes: RoSS.pFTU XL is a high-performance freezer for large batches of biopharmaceutical products.
It can cope with up to 500L per batch and is designed to be integrated in precision fermentation and other large-scale biopharmaceutical processes. The innovation of the device is based on plate freezing of multiple 50L single-use bags, making plate freezing technology accessible in the processing of such volumes. Previously, the industry was limited to often less suitable options, such as blast freezing or spray drying.
Big market – high demands: bulk freezing of ferments
Microbial fermentation (also known as precision fermentation) is becoming an increasingly important procedure in the production of various highly potent active pharmaceutical ingredients (HPAPI), including biopharmaceuticals for novel therapeutic applications. This development will continue in the coming years, as highlighted in a recent report from Future Market Insights: as of 2023, the overall microbial fermentation technology market is valued at an approximate US$32 billion (with a share of 41 % for biopharma companies) and expected to scratch the mark of US$57 billion by 2033.
A high product yield is one of the main advantages of precision microbial fermentation in the biopharmaceutical industry. But how about handling these bulk ferments of hundreds of litres? This constantly growing approach in biopharmaceutical manufacturing involves the processing of considerable amounts of biomass.
Logistics are getting more complex when different production steps based on microbial fermentation are carried out at different locations. Daniel Tischler at Single Use Support points out: “Cold chain management of such large volumes can be complex. It is necessary to freeze, transport and store large amounts of bulk intermediates. Safety and process efficiency during cold chain are of utmost importance for the respective substances.”
Conventional methods, such as static and blast freezers, are often not capable of filling and freezing such extremely large batch sizes in such a short time in a satisfactory manner. The risks of conventional freezing processes of single-use bioprocess containers include uncontrolled freezing rates, high product losses, and high microbial contamination.
Fermentation processes in the biopharma industry: the limits of spray drying
Spray drying is a commonly used technique for storage and shipping associated with microbial fermentation. In this process, the evaporated ferments are exposed to hot air, which dries the solution and produces a powder, ready for further processing.
This procedure, though, brings thermal and mechanical stress to the ferment and can have a considerable impact on its viability and quality: market insiders estimate that spray drying leads to product loss of up to 30%. It is likely that as the microbial fermentation market grows, product, time and financial losses would increase accordingly.
Plate freezing in microbial fermentation
The idea behind the development of Single Use Support’s RoSS.pFTU XL was to extend the advantages of plate freezing to the field of microbial fermentation: for example, the risk for cryoconcentration can be reduced significantly, as predefined freezing rates can lead to an accelerated and more homogeneous freezing process.
“Plate-based freezers provide manufacturers with more control over freezing processes. It therefore helps to prevent degradation of sensitive biopharmaceutical substances by a uniform freezing process”, says Tischler. “Additionally, unlike using stainless steel vessels, single-use solutions allow for a higher level of scalability as well as overall faster and more controlled freezing of large volumes.”